510(k) · Cleared
ClearedDRI TM Tricyclics Serum Tox Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
Cleared on Dec 21, 2022 as substantially equivalent to K983268 (Diagnostic Reagents, Inc., 1998) after a 373-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Dec 21, 2022
- Review
- 373 days
- Class
- Class II
- Product code
- LFH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983268 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK983268 Modification of Tricyclic Serum Tox Eia AssayDiagnostic Reagents, Inc. · 1998
- This deviceK213875 DRI TM Tricyclics Serum Tox AssayMicrogenics Corporation · 2022
- Descendant · cites it directly · 0 of its ownK231020 Alinity c Tricyclic Antidepressants Reagent KitMicrogenics Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K231020Alinity c Tricyclic Antidepressants Reagent KitMicrogenics Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983268 | Modification of Tricyclic Serum Tox Eia Assay | Diagnostic Reagents, Inc. | 1998 | — |
| 0 (this device) | K213875 | DRI TM Tricyclics Serum Tox Assay | Microgenics Corporation | 2022 | — |
| +1 | K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFH device
- #1 K231020 Alinity c Tricyclic Antidepressants Reagent Kitscore 6.7 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983268 | Modification of Tricyclic Serum Tox Eia AssaySummary page 4…turer: Microgenics Corporation Predicate Device Common Tricyclic Serum Tox Assay Name Predicate Device Premarket K983268 Notification #: Predicate Device Product LFH, Class II, Code, Classification,… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K231020 (Microgenics Corporation, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFH devicesLFH U.V. Spectrometry, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LFH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFH
Too few LFH 510(k)s in any year since 2007 to give a median.
Recalls per year · LFH
No recall names LFH since 2007.
Adverse event reports per year · LFH
1in 2007
MAUDE reports naming product code LFH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DRI™ Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum, plasma, or urine of patients at a cutoff concentration of 300 ng/mL in patients suspected of drug overdose. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by…
Read the full statement (146 words)
The DRI™ Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum, plasma, or urine of patients at a cutoff concentration of 300 ng/mL in patients suspected of drug overdose.
The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
For In Vitro Diagnostic Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213875: DRI TM Tricyclics Serum Tox Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213875
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026